ref. 01246 QA Specialist – Compliance and Quality Systems Exciting opportunity for a QA Specialist to join our client, a leading Pharmaceutical company located in Dunboyne, County Meath. Role This role will primarily provide support for SAP Quality Master Data build, Master Data approvals hypercare, sustainment, and ongoing updates in addition to providing support interface of SAP with IPI Product structure and MES BOMs and recipes, among other activities relevant to the position. You will work closely with the Operations, Engineering, Validation, Supply Chain and AR&D Functions to ensure compliance to Global and Regulatory Quality Management System requirements as they pertain to the company’s Quality Manual, Change Control, Deviation Management, Supplier Quality Management, Quality Risk Management, Audit Management and associated electronic systems. Responsibilities • Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes. • Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones. • Support implementation and training for site Quality Systems and ensures activities align with the current Quality Manual Requirements • Create and maintain assigned SOPs. • Support completion of Quality Systems activities e.g. related to Documentation Management, Auditing, Deviation Management, Change Control, Supplier Management and Quality Risk Management, per schedule • Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility. • Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation. • Support site QA Operations and QA Validation colleagues, as required. • Work collaboratively to guarantee strong relationships with management and colleagues and to drive a safe and compliant culture. • Ensure the escalation of compliance risks to management in a timely manner. • Support gathering of site metrics. • Additional activities as assigned by the manager/supervisor Requirements • 2-3 years’ experience in an FDA / EMA regulated environment,ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry. • Experience in QMS development and maintenance. • Bachelor’s Degree or higher, in a Life Science discipline. • Proven experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving. • Previous experience in quality management systems such as Veeva, SAP, Delta-V, TrackWise, PAS-X etc. or similar. • Strong attention to detail and precision in preparing and reviewing GMP documentation. • Strong written and verbal communication skills. • Knowledge of major Health Authority Guidelines and Regulations related to Biologics and/or Pharmaceuticals. • Ability to work as part of a team and on own initiative in a constructive manner. #J-18808-Ljbffr
Lead Instrumentation - Dublin - Asset Recruitment Asset Recruitment Dublin 5 days ago Full time Description The Lead Instrumentation & Controls Engineer will join a site team supporting major projects in the Pharmaceutical sector. About this role Responsible for managing the utilization, growth and development of professionals in the Instrumentation & Controls team. The main purpose of this role is to ensure consistent and high-quality deliverables of projects. Responsibilities Lead and work as part of a team, supervising and delegating to other engineers. Define an appropriate workflow process to achieve the project's purpose. Attend meetings and regularly interact with clients, project managers, and discipline leaders to develop project scope, cost, complexity, and planning requirements. Manage and ensure the scope of I&C is delivered on schedule and executed within available budget. Develop detailed design deliverables and construction packages for I&C contractors. Requirements Minimum of 10 years of experience with a proven track record of delivering the I&C scope for Pharmaceutical projects or similar areas. A BEng (Hons) in Instrumentation and Control Engineering or similar discipline. Proficiency in Instrumentation Specification, Indexes/IO lists, filed network design, panel design, construction packs, FATs, URS / Specification / SOW generation, and technical knowledge to ensure compliance with site procedures and regulations. Progressive capacity and management aptitude to plan, organize, and coordinate technical work, and obtain collaboration from others. Problem-solving skills, analytical thinking, excellent communication skills, team building, and strong work ethic. Salary: Estimated salary: £80,000 - £110,000 per annum based on location and industry standards. #J-18808-Ljbffr
ref. 01244 QA Operations Specialist Fantastic opportunity for a QA Operations Specialist to join our client, a leading Pharmaceutical company located just outside of Dublin. Role The QA Operations Specialist will lead Quality Assurance, being a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations. Primary responsibilities involve maintaining cGMPs for assigned areas in conformance with policies and in compliance with cGMPs and Health Agency regulations and all other applicable governing regulations and provide quality support to the site, including training and guidance on the interpretation and implementation of company Guidelines / Policies and regulatory requirements, as required. The ideal candidate will have fulfilled the educational requirements for this role and have the necessary experience within an FDA/EMEA regulated environment. Responsibilities Lead, facilitate and participate daily on cross-functional teams to collaboratively address compliance issues and achieve project milestones. Participate in investigations and risk assessments related to deviations/complaints and changes, ensuring appropriate actions are implemented timely. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs and related documentation for compliance to GMP and site requirements at the facility. Complete QA operational duties related to product disposition including in-coming material release and the performance of detailed review of eBR prior to QP release. Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility. Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required. Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required. Assist in the creation and maintenance of QA policies, SOPs and reports in line with site requirements. Participate in and support risk management activities in line with relevant guidance and best industry practice. Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements. Ensure the escalation of compliance risks to management in a timely manner. Assist in the execution of the internal audit programme including the performance of audits as required. Work collaboratively to promote strong relationships with management and colleagues while driving a safe and compliant culture. Requirements A Degree qualification (Science/Quality/Technical). 8-10 years of experience, ideally in Quality Assurance, Technical Operations or Quality Control within the Biological and/or pharmaceutical industry. Project Manager capability with strong understanding of Operations. Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME. Strong written and verbal communication skills. Experience in quality management systems such as Veeva, SAP, PAS-X etc. Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals. Strong attention to detail and accuracy in preparing and reviewing GMP documentation. Experience in direct interactions with regulatory authorities during site inspections. #J-18808-Ljbffr
ref. 01242 Senior Mechanical Quantity Surveyor Our client, a prominent EPCM consultancy company, is seeking a Senior Mechanical Quantity Surveyor for an, initially 12 Month contract position. • The project is based in Ballydine and offers hybrid working option. • The role will include all aspects of Quantity Surveying both pre and post contract across a variety of sectors. • Reporting directly to the Commercial Manager, the successful candidate will have the ability of working independently and as part of a larger team. Responsibilities: Pre-Contract responsibilities: • Preparing capital cost estimates • Assisting in tendering procedures and contract arrangements • Prepare pricing documents for tender packages During the tendering phase responsibilities: • Providing advice on tendering procedures • Draft instructions to tenderer’s • Development of tender evaluation criteria • Drafting of PQQ questionnaires • Commercial evaluation of all tender submissions • Handling queries during tender period • Negotiation with tenderer’s Post Contract duties: • Reporting to the Commercial Manager and responsible for commercial aspects on the project. • Preparation of Interim Valuations. • Preparation of monthly Cost Reporting. • Client and Contractor meetings. • Negotiation and agreement of Variations. • Review and assessment of Contract Claims. • Agreement of Final Accounts The ideal candidate will have: • A Quantity Surveying degree • Experience in the Construction Industry. • Ability to work well within a team and to collaborate with others. • Must have commercial knowledge, be flexible and have ambition to progress within the organisation. • Time management skills to maximize efficiency and meet challenging work goals. • Determination to drive and manage strict budgets to ensure the commercial success of the project. #J-18808-Ljbffr
ref. 1243 Project Engineer Asset Recruitment is seeking experienced Project Engineers to join our client’s dynamic management team and support biopharmaceutical projects in the Dublin region. The ideal candidate will bring 5+ years of experience in CGMP regulated environments along with processing equipment specification, commissioning, and operation. This is an exciting role for a motivated engineer who thrives in on-site roles. The successful candidate will plan and execute projects, demonstrate strong communication skills and coordinate technical and project support as necessary. Responsibilities • Lead and manage the delivery of projects across site, ensuring compliance in terms of life cycle management, documentation, adherence to schedule, safety protocols and regulatory requirements • Plan, execute and track the progress of projects through the design phases from inception to handover including leading the development of design and installation specifications along with commissioning plans, including site walks and system acceptance reviews. • Lead construction project activities- day to day, vendor management / permitting /PSCS • Create and review project engineering deliverables such as technical specifications, procurement submittals and vendor turnover documentation. • Settle robust plans and strategies in place to manage the project lifespan • Communicate project issues and follow-up with the right skill sets to put best solutions in place on time and within budget • Manage vendors on site and ensure project works meet site permitting requirements – developing KPI’s and governance process for Project performance, report out and action tracking • Identify Risks and Opportunities related to activities – work with Area Owners and SME’s to develop contingency, remediation, modification, or replacement activities. • Ensure that all asset changes and projects have the correct assessments to ensure compliance ahead of becoming operational, including MRO requirements, risk management and business continuity impact. • Ensure that the documentation hand over and project close out is completed in compliance with site governance processes • Ensures effective communication throughout project lifecycle by reporting to management on project activities, and KPIs including schedule and cost adherence. • Participates in, contributes, and influence the development of the site long range capital plan Requirements To excel in this role, you will more than likely have: • A 3rd level qualification in Engineering (Chemical, Process, Mechanical or equivalent) • 5+ years’ post grad experience. • Project and/or operations experience within a process or biopharmaceutical cGMP regulated environment. • Experience of processing equipment specification, commissioning, and operation. • Demonstrated ability to work cross-functionally both at a site and global level • Knowledge of Project and vendor management and Industry Best Practices. #J-18808-Ljbffr
ref. 01241 CQV Engineers x 5 – Downstream Equipment, TCUs & Delta V Asset Recruitment is seeking CQV Engineers with experience in Downstream equipment (SUMs and Chromatography), TCUs and Delta V, to join our client’s EPCM team in a Biopharma project based just outside Dublin. This is a 12-Month contract role opportunity initially. Work Location: onsite – Dunboyne, Co. Meath. Responsibilities • Review and follow-up technical documentation from the early design phase to ensure alignment with GMP and CQV requirements • Investigate and resolve technical issues with assistance from engineers and/or suppliers • Ensure site project execution is undertaken in compliance with company guideline, department procedures and safety standards • Project management principles to coordinate CQV activities and reporting to the project manager and Clients PM • Schedule preparation and progress review • Management and coordination of Contractors and Vendors • Final Handover reports to the Client users Requirements • Experience in Downstream equipment (SUMs and Chromatography), TCUs and Delta V • Degree or equivalent qualification in an Engineering related discipline • Strong experience in project procedures and commissioning and qualification protocols (SAT/Commissioning, IQ and OQ) • Be familiar with the Mechanical Completion procedure and Construction scope of work (Walkdown, system acceptance, punch list and follow up) #J-18808-Ljbffr
ref. 01217 Lead Process Engineer Asset Recruitment is seeking a Lead Process Engineer to join our client’s multi discipline process team. The Lead Process Engineer will oversee and guide the process design development, offering technical leadership and direction throughout the project. They will ensure the project meets the necessary design criteria and client requirements, focusing on timely delivery, productivity, and quality. In this role, they will manage, inspire, and drive project teams, utilizing their technical expertise, interpersonal skills, and conflict resolution abilities. Qualifications • A bachelor’s degree in Chemical Engineering with at least 7-10 years of experience in the design of process systems in Pharmaceutical/Nutritional/Medical devices • Knowledge of relevant cGMP requirements and ISPE Baselines • Fluency in English. Italian knowledge extremely fluent/mother tongue • Software knowledge: Office; Super Pro(R) & Schedule Pro(R), PipeFlo, Flexsim, or other process engineering simulations software • Willingness to work in an international company, to share and capitalize expertise with other offices Process Design Basis •Applies process design criteria, guidelines and contract requirements to process design work. •May be responsible for interacting with licensors, including establishing design basis and license or evaluation. •Applies process design criteria and guidelines to all phases of process engineering. Flow Diagrams •Prepares flow diagrams and participates in flow diagram reviews. •Is able to prepare and review flow diagrams with total information to correspond to the flow sequence, operability and the safety of the unit/system. •Answers questions, with confidence, from other disciplines and clients as to the requirement / function of each item on the flow sheet. •Prepares and reviews metallurgy flow diagrams. •Back checks, updates, and ensures consistency with related design documents such as specification sheets and with other units. Equipment Datasheets •Prepares process and utility equipment specification sheets. Might be responsible for design of a system or a complete unit. •Prepares equipment duty specifications for all equipment including complex equipment such as reactors. •Prepares detail design specification for all equipment. •Reviews input from other disciplines for compatibility with process design for all equipment. Control Philosophy •Prepares instrumentation process data. Assists in establishing control philosophy for relatively complex control systems to meet process objectives, including safety. •Prepares control valves process data, relief valve data, analyser data. •Interprets control philosophy of relatively complex control systems. •Reviews control systems specification sheets for consistency with process data •Reviews logic diagrams for relatively simple loops. •Evaluates alternative control strategies to meet process objectives. Calculations •Performs specifications/calculations and technical studies. •Completes conceptual developments of a major system and performs all necessary calculations for process design of systems and equipment within the assigned area. •Ensures that calculations are legible, well organized, correctly references as to equipment/system, dated and signed. •Performs relatively complex technical studies under general supervision. Equip Selection/Review •Reviews and approves equipment bid tabulations and vendor data. •Ensures consistency of vendor data with other design documents such as flow diagrams, area classifications drawings, utility summaries, etc •Expeditiously reviews equipment requests for quotes, purchase requests, bid tabulations and vendor data for conformance to specifications, process compatibility, safety and operability. Plant Safety/Operability •Responsible for performing various process engineering work functions in a manner that will provide a safe and operable plant •Understands obligations and authority to make appropriate design decisions necessary for plant safety and operability. •Reviews the unit/plant layout for unsafe piping/equipment arrangement and for adequate access to critical valves. •Identifies potentially lethal/toxic substances and designs the systems handling those substances in accordance with established procedures. •Assists in specification of any required safety systems (eye-washers, safety-showers, gas detectors, etc). Operating Manual •Assists in the production of plant operating manuals. May assume overall responsibility for manuals relatively less complex units. •Understands and applies guidelines developed by others regarding the required contents of the operating manuals. •Writes assigned sections of the manuals for complex units or writes complete manuals for less complex units. The manuals should be technically correct, complete and clearly written. Field Work •Assists in process fieldwork. •Shows a willingness to accept field assignments to fulfill project requirements (personal circumstances permitting). •Performs, under genera supervision, a plant checkout as required to ensure flow diagrams and designs have been correctly implemented and all tie-in correctly located. •Assists, under general supervision in operator training programs and in plant start-up and /or plant performance testing as required. •Assists, under general supervision, in writing of the Process Final Job Report. #J-18808-Ljbffr
ref. 01105 Lead I&C Engineer The Lead Instrumentation & Controls Engineer will join a site team supporting major projects in the Pharmaceutical sector. Responsible for managing the utilization, growth and development of professionals in the Instrumentation & Controls team. The mainly purpose of this role is to ensure consistent and high quality deliverables of projects. Responsibilities •To lead and work as part of a team and supervising and delegating to other engineers. • Defines an appropriate workflow process to achieve the projects purpose • Attend meetings and regularly interact with clients, Project managers, and discipline leaders to develop project scope, cost, complexity and planning requirements of projects • Manage and ensure scope of I&C is delivered on schedule and executed within available budget • Develop Detailed Design deliverables and construction packages for I&C contractors Requirements • Minimum of 10 years of experience with a proven track record of delivering the I&C scope for Pharmaceutical projects or similar areas. • A BEng (Hons) in Instrumentation and Control Engineering or similar discipline. • Instrumentation Specification, Indexes/IO lists, filed network design, panel design, construction packs, FATs etc. • URS / Specification / SOW generation • Technical knowledge to ensure that all new equipment is bought in accordance with appropriate site procedures & regulations. • Progressive capacity and management aptitude to plan, organize and coordinate technical work and to obtain collaboration from others. • Problem solving skills and Analytical thinking. • Excellent communication skills, team building and strong work ethic. #J-18808-Ljbffr
ref. 01239 Project Construction Planner Asset Recruitment is recruiting a Project Planner for a contract role, on behalf of our client, a leading EPCM company. This position involves working on a large-scale Bio-Pharma construction project in Limerick. Minimum site attendance of 4 full days per week, collaborating with an already established project planning team. The ideal candidate will have a minimum of five years’ experience in pharmaceutical construction and hold a degree in Engineering, a technical discipline, or a similar field. Responsibilities • Lead Project Schedule for the EPCM (Engineering, Procurement, Construction and Management) Project Scope. • Coordinate meetings and manage interactive planning. • Manage and interface with subcontractors. • Establish and run an earned value progress reporting system. • Good understanding of design deliverables and subcontractor mobilization activities Requirements • Minimum of 5 years’ experience. • Strong Pharmaceutical Background • Proven experience working within a team of planners • 4D BIM experience is advantageous. • Excellent computer skills, including Primavera P6, Microsoft Project, and MS Office Suite • Previous experience working in a multi-user P6 environment (e.g., Loadspring) • Excellent interpersonal and communication skills • Experience with Last Planner interface • Good understanding of broader project controls functions and contractor interfacing, including tender milestones, contract milestones, extension of time evaluations. #J-18808-Ljbffr
ref. 01238 Process Project Engineer Asset Recruitment is recruiting a Process Project Engineer for a contract role (initially 11-Month duration), on behalf of our client, a growing pharmaceutical manufacturer in Carlow. You will join the Technical Engineering Department, leading an integrated project team in delivering the project business case. You will be involved in Process Improvements, capital projects and lean projects across multiple functions. Responsibilities • Manage projects from scope development, design, build/install and qualify through to handover to operations for key Technical Engineering projects. • Responsible, with the Project Manager, for the development and maintenance of the scope, budget and timelines. Adequately resource core team in support of scope and schedule targets. • Maintain direct contact with the Project Sponsors to ensure engineering solution development remains aligned with the project’s business case. • Coordinate and present of the typical project Stage Gates to off-site Capital Approval Committee. • Develop project scope, cost and delivery time schedule for all Tech Eng projects, working and collaborating closely with technical engineering leads to ensure integration into ongoing Validations and/or Technical transfers. • Work with cross functional teams to establish scope in improvement projects as we ramp up to a fully commercial site. • Use scientific, product and process understanding as a basis for developing risk-based approaches to investigations and troubleshooting that will feed into future projects. • Serve as a subject matter expert on: equipment design and qualification; assisting in C&Q execution planning; system boundary definition, system level and component criticality impact assessments, use of quality risk management, User Requirement Specs and requirements traceability matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development, project implementation. • Sponsor and foster lean six sigma and standard work within the technical engineering Team (e.g. Structured Root Cause Analysis, Statistical Process Control, Data driven decision making). • Active participate in projects, system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate to drive and support continuous improvement. • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system. • Integrate Computer Systems Validation activities into required projects, in collaboration with Automation/IT partners. • Foster collaboration between groups within the Technical Engineering function proactively looking for synergies and innovative ways of doing work. • Continuously evaluate systems and processes to identify opportunities for smarter, more efficient and compliant operations. • Serve as a liaison with both global engineering services and facilities as well as specialist vendors to deliver projects on time and in full as required by the business. • May be required to perform other duties as assigned. Requirements • The ideal candidate will have experience as a Capital Projects Team Lead for large capital projects (>$5MM). • Bachelor’s degree in a Science, technical or Engineering discipline. • 7+ years’ experience in a similar role (Process/Project/CQV activities) • Would typically have experience operating as a senior professional and adding considerable value to the business. Would have process engineering and/or validation experience in a sterile manufacturing environment and have a proven track record in leading a technical team of engineers / scientists through sustaining operations and technical transfer projects. Experience in leading through change would be an advantage. • Good knowledge of shipping/Filter/Cleaning validation. • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. • Automation and MES knowledge. • Proficiency in Microsoft Office and job-related computer applications required • Excellent communication, presentation and interpersonal skills. • Proven contractor and vendor management skills. • Proven record in planning and basic project management of a team to deliver on time/schedule and cost. Desirable • Lean Six Sigma Methodology experience. • Experience in audit preparation and execution. • Knowledge of QbD/CPV. #J-18808-Ljbffr
